BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT HIV AG/AB COMBO

    MDR report key: 2983393 · Received February 28, 2013

    Report

    Report Number
    3002809144-2013-00030
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MZF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT (CATALOG #04J27) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S. (CATALOG #02P36). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    REVIEW OF COMPLAINT TEXT SHOWED THAT USER INJURY IS RELATED TO INCORRECT USE SINCE THE CUSTOMER CAME IN CONTACT WITH ASSAY DILUENT (MOUTH AND SKIN) AFTER REMOVAL OF THE SEPTUM FROM THE SPECIMEN DILUENT BOTTLE, ALTHOUGH ACCORDING TO THE ARCHITECT OPERATION MANUAL AND THE PACKAGE INSERT FOR THE ARCHITECT HIV AG/AB COMBO ASSAY, THE SEPTUM SHOULD NOT BE REMOVED FROM THE BOTTLE. REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. COMPLAINT TRACKING AND TRENDING REVIEW DETERMINED THAT THERE ARE NO ADVERSE TRENDS AND NO NON-STATISTICAL TRENDS IDENTIFIED FOR THE COMPLAINT ISSUE. BASED ON THIS DATA, THE PRODUCT IS PERFORMING AS INTENDED AND NO PRODUCT ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT WHILE REMOVING THE RUBBER SEPTUM FROM THE DILUENT REAGENT BOTTLE FOR THE ARCHITECT HIV AG/AB COMBO ASSAY, SHE ACCIDENTALLY SPILLED A FEW DROPS OF THE DILUENT IN HER MOUTH AND ON HER SKIN. THE INCIDENT OCCURRED ON (B)(6) 2013. THE CUSTOMER RINSED HER MOUTH AND SKIN WITH WATER AND STATED THAT SHE FELT FINE. FOLLOW-UP WITH THE CUSTOMER WAS ATTEMPTED ON (B)(6) 2013 TO MAKE SURE SHE WAS STILL FEELING FINE AND THAT NO TREATMENT WAS SOUGHT, BUT SHE WAS ON VACATION. UPON FOLLOW-UP WITH THE CUSTOMER ON (B)(6) 2013 SHE INDICATED THAT SHE HAD CONTACTED THE ANTI-POISON CENTER AND UNDERWENT CARDIAC MONITORING FOR 6 HOURS AND DRANK ONE LITER OF ACTIVATED CARBON. THE RESULTS FROM THE CARDIAC MONITORING WERE NORMAL. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85973 ARCHITECT HIV AG/AB COMBO MZF ABBOTT GERMANY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ARCHITECT I1000SR ANALYZER| ARCHITECT I1000SR ANALYZER| LIST 01L86-01, SERIAL (B)(4)| LIST 01L86-01, SERIAL (B)(4)